Wednesday, January 27, 2016

The Letter: US Government Says Theranos Lab Poses 'Immediate Jeopardy to Patient Safety'---UPDATED

The Centers for Medicare and Medicaid Services has decided that Theranos' Newark, California, facility poses "immediate jeopardy to patient safety." A letter sent to the company on January 25th says that the lab has been given 10 days to comply with "acceptable evidence of correction."

Specifically, the document cites problems with the laboratory director, the technical supervisor, hematology, and the lab's systems. CMS has not released the laboratory inspection report that led to this letter so the details of these infractions remain unclear. But the level assigned to these determinations — "Condition-level deficiencies" — are among the most serious that CMS can make. They mean that Theranos’ Newark lab was found to be in violation of accepted professional standards.

Developing...

Update: Bloomberg has some reaction from the company:

“This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab,” Brooke Buchanan, a Theranos spokeswoman, said in an e-mail. “As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems....”